Sklar

Basic Information

• Brand Name: Sklar
• Primary DI: 30649111211885
• Version / Model: 85-2555
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-05-21
• Public Version: 1
• Public Version Date: 2019-05-29
• Public Version Status: New
• Public Device Record Key: 4d7e94b3-8236-4e75-8354-fc58813f15dd

Device Description

GUYON SOUND W/O THREAD SET/20

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FBX	SOUND, URETHRAL, METAL OR PLASTIC	Gastroenterology, Urology	876.5520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13643	Urethral sound, reusable	A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30649111211885	GS1
Unit of Use	00649111211884	GS1